More than 100 people who claim they developed gambling and pornography habits after taking drugs used to treat tremors caused by Parkinson’s disease have filed a class-action lawsuitin Australia against Pfizer as well as Aspen Pharmacare, The Sydney Morning Herald reports.
Some of the plaintiffs claim they lost hundreds of thousands of dollars and suffered family breakdowns thanks to the compulsive behavior allegedly linked to the pills. Most developed gambling addictions but a few exhibited compulsive sexual behaviour such as looking at pornography on the Internet, the paper continues. The lawsuit claims Pfizer, which sold Cabaser, and Aspen, which sold Permax, failed to provide adequate warnings of increased risk of compulsive disorders.
This is by no means the first time such litigation has been prompted by a class of pills known as dopamine agonists, which cause a rush and have been linked to risky behavior. In 2008, a jury in Minnesota awarded $8.2 million to a man who became a compulsive gambler after using Mirapex, which is sold by Boehringer Ingelheim, to treat Parkinson’s disease .
Last month, by the way, a study published in the Archives of Neurology found that dopamine agonist treatment for Parkinson’s disease was associated with increasing the odds of developing an impulse control disorder - such as gambling, binge eating and compulsive shoping - by two to 3.5 times.
Read complete post here..
http://www.pharmalot.com/2010/06/pfizer-sued-over-pill-for-sex-gambling-addictions/
Saturday, June 5, 2010
Tuesday, June 1, 2010
Depressed? You’re Likely To Get An Antidepressant
This isn’t surprising. A new survey finds that 78 of those seeking treatment for depression or anxiety were prescribed antidepressants, but roughly half of those taking such a pill report being helped ‘a lot.’ Meanwhile, 91 percent of respondents who stuck with ‘talk therapy, reported this approach made things “a lot” or “somewhat” better, according to Consumer Reports, which conducted the survey.
The survey also found that older, often less expensive SSRI antidepressants - selective serotonin reuptake inhibitors such as Lexapro, Celexa, Prozac and Zoloft - work just as well, and with fewer side effects, than newer, more costly SNRIs, including Cymbalta and Effexor (see Consumer Reports cost data here). Last year, doctors prescribed $9.9 billion worth of antidepressants, a 3 percent increase, according to IMS Health.
“Our survey shows that a combination of therapy and medication works best, and that despite the intense marketing push consumers are subjected to,” Nancy Metcalf, senior program editor for Consumer Reports Health, says in a statement, “there is no evidence that newer drugs like Pristiq and Cymbalta work any better than older medications in their class.”
Among those taking SSRIs, 53 percent say they helped “a lot,” compared with 49 percent given SNRIs. As to side effects, 31 percent of those on SSRIs reported sexual side effects, 16 percent cited weight gain and 12 percent had sleep problems. Of those taking SNRIs, 36 percent reported sexual side effects, 22 percent had weight gain and 16 percent cited sleep problems. Wellbutrin, which is also known as Bupropion and is neither an SSRI nor an SNRI, helped 48 percent of respondents “a lot.” In terms of sexual side effects and weight gain, it was tolerated better than the SSRIs and SNRIs.
The survey also found that older, often less expensive SSRI antidepressants - selective serotonin reuptake inhibitors such as Lexapro, Celexa, Prozac and Zoloft - work just as well, and with fewer side effects, than newer, more costly SNRIs, including Cymbalta and Effexor (see Consumer Reports cost data here). Last year, doctors prescribed $9.9 billion worth of antidepressants, a 3 percent increase, according to IMS Health.
“Our survey shows that a combination of therapy and medication works best, and that despite the intense marketing push consumers are subjected to,” Nancy Metcalf, senior program editor for Consumer Reports Health, says in a statement, “there is no evidence that newer drugs like Pristiq and Cymbalta work any better than older medications in their class.”
Among those taking SSRIs, 53 percent say they helped “a lot,” compared with 49 percent given SNRIs. As to side effects, 31 percent of those on SSRIs reported sexual side effects, 16 percent cited weight gain and 12 percent had sleep problems. Of those taking SNRIs, 36 percent reported sexual side effects, 22 percent had weight gain and 16 percent cited sleep problems. Wellbutrin, which is also known as Bupropion and is neither an SSRI nor an SNRI, helped 48 percent of respondents “a lot.” In terms of sexual side effects and weight gain, it was tolerated better than the SSRIs and SNRIs.
Monday, May 31, 2010
Generic Drugmakers Lose Preemption Argument
A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.
In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .
The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote.
Some background: In 2003, GlaxoSmithKline released Wellbutrin XL, an extended-release form of the pill that could be taken just once daily and used a membrane-release technology, which meant the drug would seep at a controlled rate through a membrane that passed through the entire body intact, The Legal Intelligencer writes.
Since the membrane technology was patented, generic manufacturers who wanted to release a version of Wellbutrin XL were forced to devise their own methods of delayed release. Impax and Teva used a different matrix technology and their drugs achieved peak concentrations in two hours. Wellbutrin XL and generic versions made by other companies achieved this in five hours.
For patients who switched, the faster release made the drug less effective in combating depression, according to the lawsuit, which alleges neither Impax nor Teva took steps to warn doctors or patients that their versions worked differently or disclosed side effect complaints.
“Levine teaches that the ultimate responsibility rests with the drug maker, not the FDA, to either adequately inform the public or remove the drug from the market,” Schiller wrote. “Defendants have offered no compelling reason why Congress would have given generic drug makers favored status.”
Original News Source:
http://www.pharmalot.com/2010/05/generic-drugmakers-lose-preemption-argument/
In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .
The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote.
Some background: In 2003, GlaxoSmithKline released Wellbutrin XL, an extended-release form of the pill that could be taken just once daily and used a membrane-release technology, which meant the drug would seep at a controlled rate through a membrane that passed through the entire body intact, The Legal Intelligencer writes.
Since the membrane technology was patented, generic manufacturers who wanted to release a version of Wellbutrin XL were forced to devise their own methods of delayed release. Impax and Teva used a different matrix technology and their drugs achieved peak concentrations in two hours. Wellbutrin XL and generic versions made by other companies achieved this in five hours.
For patients who switched, the faster release made the drug less effective in combating depression, according to the lawsuit, which alleges neither Impax nor Teva took steps to warn doctors or patients that their versions worked differently or disclosed side effect complaints.
“Levine teaches that the ultimate responsibility rests with the drug maker, not the FDA, to either adequately inform the public or remove the drug from the market,” Schiller wrote. “Defendants have offered no compelling reason why Congress would have given generic drug makers favored status.”
Original News Source:
http://www.pharmalot.com/2010/05/generic-drugmakers-lose-preemption-argument/
Sunday, May 30, 2010
Novo Nordisk Pulls Insulin From Greece Over Money
More fallout from the European debt crisis. Novo Nordisk has yanked its diabetes product from Greece after the government instituted substantial price cuts of up to 25 percent on hundreds of medicines (see background), which the Danish drugmaker claims would force it to lose money on top of the $36 million it is already owned by Greek government.
More than 50,000 Greek diabetics use Novo Nordisk’s insulin product, which is injected with a fountain pen-like device and, not surprisingly, a patient association called the move a “brutal capitalist blackmail” and a “violation of corporate responsbility,” according to the BBC.
Pavlos Panayotacos, whose 10-year-old daughter has diabetes, wrote to Novo Nordisk ceo Lars Sorensen to say that, “as an economist I realize the importance of making a profit, but healthcare is more than just the bottom line. As you well may know, Greece is presently in dire economic and social straits, and you could not have acted in a more insensitive manner at a more inopportune time.”
However, Sorensen is having none of it. He wrote back to say the decision was prompted by “the irresponsible management of finances by the Greek government which puts both you and our company in this difficult position,” the BBC reports. A Novo Nordisk spokesman says the issue is not about killing people and, to compensate, the drugmaker will make available its glucagen insulin free of charge.
Novo Nordisk is also concerned that the price cuts will have a ripple effect elsewhere in Europe, because other countries use Greece for as a reference point for setting drug prices.
More than 50,000 Greek diabetics use Novo Nordisk’s insulin product, which is injected with a fountain pen-like device and, not surprisingly, a patient association called the move a “brutal capitalist blackmail” and a “violation of corporate responsbility,” according to the BBC.
Pavlos Panayotacos, whose 10-year-old daughter has diabetes, wrote to Novo Nordisk ceo Lars Sorensen to say that, “as an economist I realize the importance of making a profit, but healthcare is more than just the bottom line. As you well may know, Greece is presently in dire economic and social straits, and you could not have acted in a more insensitive manner at a more inopportune time.”
However, Sorensen is having none of it. He wrote back to say the decision was prompted by “the irresponsible management of finances by the Greek government which puts both you and our company in this difficult position,” the BBC reports. A Novo Nordisk spokesman says the issue is not about killing people and, to compensate, the drugmaker will make available its glucagen insulin free of charge.
Novo Nordisk is also concerned that the price cuts will have a ripple effect elsewhere in Europe, because other countries use Greece for as a reference point for setting drug prices.
Saturday, May 29, 2010
Generic Drugmakers Lose Preemption Argument
A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.
In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .
The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote
In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .
The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote
Monday, May 24, 2010
Orgasm Inc: Female Sexual Dysfunction Is curable
Next month, an FDA advisory committee will meet to review a Boehringer Ingelheim pill to tackle FSD, or female sexual dysfunction . However, a growing group of psychologists, academics and public health advocates contend that FSD isn’t an authentic medical condition, or at least not the sort of problem that should be treated with drugs. Bandied about but never proven is the statistic that 43 percent of women suffer from this affliction (background).
And so just in time for the regulatory show comes a new documentary called Orgasm Inc. (subtitled The Strange Science of Female Pleasure), which premieres in New York on Thursday and explores the issue by examining a host of views and products, including the Orgasmatron and an effort by Vivus Pharmaceutical to develop and sell a topical treatment. “A lot of this is about marketing,” filmmaker Liz Canner tells Newsweek. “They are trying to sell disorders.” You can read more here.
And so just in time for the regulatory show comes a new documentary called Orgasm Inc. (subtitled The Strange Science of Female Pleasure), which premieres in New York on Thursday and explores the issue by examining a host of views and products, including the Orgasmatron and an effort by Vivus Pharmaceutical to develop and sell a topical treatment. “A lot of this is about marketing,” filmmaker Liz Canner tells Newsweek. “They are trying to sell disorders.” You can read more here.
Sunday, May 23, 2010
Congress Will Hold J&J Recall Hearing This Week
Despite a request by a fellow committee member to postpone a hearing into the Johnson & Johnson recall scandal, House Committee on Oversight and Government Reform chair Edolphus Towns, a New York Democrat, is proceeding with plans to hold the session this coming Thursday, May 27.
You may recall earlier this week that Darrell Issa, the committee’s ranking member and a California Republican, asked Towns for a postponement because J&J ceo Bill Weldon is unable to atttend - he underwent back surgery the other day - and the FDA, meanwhile, has not yet completed its inspections of McNeil Consumer Healthcare facilities. J&J’s McNeil unit was cited for quality-control problems that affected about 40 over-the-counter meds for infants and children, and failed to properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell .
In arguing for a postponement, Issa wrote Towns; “It is my opinion that Mr. Weldon’s presence at this hearing is of the utmost importance, if for no other purpose than to restore brand confidence. According to credible sources, the McNeil manufacturing facilties presently under investigation may be ‘out of control’ and not following internal standard operating procedures, mess less FDA regulations. The parent company must be held accountable for the actions of its subsidiary and the only way to achieve this is by Mr. Weldon’s appearance before our committee.”
Towns, however, appears to believe that it’s best to strike while the iron is hot. And so he accepted a substitute for Weldon - Colleen Giggins, who heads J&J’s worldwide consumer healthcare business. The other person who was invited to testify is Josh Sharfstein, the FDA deputy commish. Towns had previously invited FDA commish Margaret Hamburg, and there was no reason given for the switch.
Source: Pharmalot.com
You may recall earlier this week that Darrell Issa, the committee’s ranking member and a California Republican, asked Towns for a postponement because J&J ceo Bill Weldon is unable to atttend - he underwent back surgery the other day - and the FDA, meanwhile, has not yet completed its inspections of McNeil Consumer Healthcare facilities. J&J’s McNeil unit was cited for quality-control problems that affected about 40 over-the-counter meds for infants and children, and failed to properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell .
In arguing for a postponement, Issa wrote Towns; “It is my opinion that Mr. Weldon’s presence at this hearing is of the utmost importance, if for no other purpose than to restore brand confidence. According to credible sources, the McNeil manufacturing facilties presently under investigation may be ‘out of control’ and not following internal standard operating procedures, mess less FDA regulations. The parent company must be held accountable for the actions of its subsidiary and the only way to achieve this is by Mr. Weldon’s appearance before our committee.”
Towns, however, appears to believe that it’s best to strike while the iron is hot. And so he accepted a substitute for Weldon - Colleen Giggins, who heads J&J’s worldwide consumer healthcare business. The other person who was invited to testify is Josh Sharfstein, the FDA deputy commish. Towns had previously invited FDA commish Margaret Hamburg, and there was no reason given for the switch.
Source: Pharmalot.com
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